Position Director, DMPK
Company ROME Therapeutics
Location Cambridge, MA
Reports to VP, Research
Who We Are
ROME Therapeutics is developing novel therapies for cancer and autoimmune diseases by harnessing the power of the repeatome – vast stretches of uncharted genetic material that have long been dismissed as “junk DNA.” With several drug targets identified and multiple discovery programs underway, ROME is moving rapidly to leverage this new frontier in biology. To lead this exploration, ROME has assembled a team of world-class leaders across fields including oncology, immunology, virology and machine learning. ROME was launched in April 2020 and was incubated at GV, in collaboration with ARCH Venture Partners and Partners Innovation Fund. ROME is based in Cambridge, Mass. For more information, please visit www.rometx.com.
What You’ll Do
- Responsible for leading the scientific, technical and operational efforts of DMPK to drive DMPK strategy of discovery and development programs
- Interact with discovery teams and drive DMPK strategy and help guide structural modifications of small molecules and biologics to improve ADME properties for lead optimization and development candidate nomination
- Design and utilize translational PK/PD modeling to guide clinical study designs and dose selection
- Direct internal and external DMPK activities, including routine studies, troubleshooting, and issue management. Identify and manage CROs regarding DMPK studies and timelines
- Independently lead IND enabling ADME/PK studies from protocol to final reports. Independently author DMPK sections of regulatory submissions (IND/CTA, IB, NDA, etc)
- Write and review technical reports, research protocols, SOPs, IND sections and scientific manuscripts for publication.
What You’ll Bring
- PhD in Pharmaceutical Sciences, Pharmacokinetics, Drug Metabolism, or a related field 10+ years experience in the pharmaceutical industry
- Proven ability to drive drug discovery projects from discovery through candidate selection and IND
- Strong scientific knowledge of drug metabolism of small molecule and biologics discovery and development programs
- In-depth conceptual and technical expertise in DMPK and PKPD areas and experience in IND filing. Capable of working independently in a team environment across biology, pharmacology, toxicology, translational, and clinical functions
- Experience with external vendor management such as CROs and consultants
- Solid grasp of ICH regulatory guidance documents relevant to ADME/PK activities supporting nonclinical development in the US and Europe
- Excellent verbal and written communication skills
- We value the strength of team development, communication and leadership that inspires motivation to drive quality research with urgency that will better patients’ lives.
- Be an active participant and ensure high quality scientific rigor
- A cutting-edge approach to drug discovery
- Effective Communication skills
- Pro-active and resourceful problem solver
- Comfortable with the ambiguity of early-stage Life Science companies
- Ability to manage multiple complex projects simultaneously
- Strong cross functional collaboration skills with a focus on trust, credibility, and mutual respect
- Asking questions, being open to new ideas and embracing ambiguity will help make you successful in this role.
- Ability and willingness to be candid and genuine
- Proven track record of demonstrating functional expertise and following through on commitments.
- Comfortable working in an initially virtual environment thru Spring of 2022
- Vaccination against COVID-19 is strongly encouraged and proof of vaccination should be provided to ROME
Who You’ll Work With
All Roman citizens exemplify our core values. Romans are encouraged to BE BOLD, DELIVER EXCELLENCE and to CARE DEEPLY in our pursuit of discovering and delivering medicines to patients in need. Relentless curiosity means that we continually strive to improve, learn, and grow by asking questions, seeking knowledge, and stretching beyond our comfort zone. We rely on each other to know our stuff, follow through and to ‘GSD – get stuff done’. We are inspired to operate with respect and kindness, valuing differences and authenticity.
COMPENSATION AND BENEFITS
ROME offers competitive compensation and benefits.
HOW TO APPLY
Please send a cover letter and a copy of your CV to email@example.com
ROME Therapeutics is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.